Risk Assessment & Management Flashcards
7 cards from real CPP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Assessment & Management flashcards as text
A packaging engineer is tasked with assessing risks for a new e-commerce packaging design. Which hazard element is most unique to e-commerce versus retail distribution?
Answer: Individual parcel handling with multiple drops and reduced secondary packaging
E-commerce packages are handled individually with frequent drops and rough parcel-carrier handling, unlike retail distribution where products travel palletized with protective outer cases.
What is the primary risk associated with excessive headspace in a hermetically sealed food package?
Answer: Higher residual oxygen content that accelerates product spoilage
Excess headspace contains more residual oxygen, which promotes oxidation, microbial growth, and flavor/color degradation in oxygen-sensitive food products.
A risk assessment identifies a potential for ink migration from printed packaging into a food product. Which control measure directly addresses this risk?
Answer: Using food-safe inks or adding a functional barrier layer between print and food contact surface
Using food-safe inks certified for direct/indirect food contact or applying a functional barrier prevents chemical migration from print layers into food.
Which concept describes the practice of building redundancy into a supply chain to mitigate single-point-of-failure risks?
Answer: Dual sourcing or multi-sourcing of critical packaging materials
Dual or multi-sourcing ensures that if one supplier fails, alternative suppliers can maintain production, reducing supply chain vulnerability.
When conducting a packaging risk assessment for a medical device, which standard provides the globally recognized framework for risk management?
Answer: ISO 14971 — Application of Risk Management to Medical Devices
ISO 14971 is the internationally recognized standard specifically governing risk management processes for medical devices and their packaging throughout the product lifecycle.
A risk mitigation strategy that involves accepting a known low-level risk without taking corrective action is called what?
Answer: Risk acceptance
Risk acceptance is a deliberate decision to acknowledge a risk and take no further action, typically when the cost of mitigation exceeds the potential impact.
In packaging validation for a sterile medical device, what does a 'worst-case' scenario test matrix ensure?
Answer: That the packaging system is validated under the most challenging but plausible conditions it will encounter
Worst-case testing validates that packaging performs acceptably even under the most extreme allowable process conditions, providing confidence that routine production will also pass.